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A Study on the Safety and Tolerability of Universal STAR-T Cell Therapy for Multiple Sclerosis.

ConditionMultiple Sclerosis (MS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDaishi Tian

About this trial

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.

The main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of the universal STAR-T cell injection in treating patients with progressive or relapsing-remitting MS; and to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection.

The primary endpoint of this study is the incidence rate of dose-limiting toxicity (DLT), as well as the types, severity and frequency of adverse events (AE).The secondary research endpoints of this study are the efficacy endpoints as well as the expansion and persistence of the universal STAR-T cells in the body.

This study is an exploratory clinical trial of the universal STAR-T cell injection for the treatment of progressive or relapsed-remitting MS. The study will be conducted in two phases: dose escalation and dose expansion. The dose escalation group 1 (1.5E6 STAR-T cells) begins, followed by dose escalation group 2 (3E6 STAR-T cells), and dose escalation group 3 (4.5E6 STAR-T cells).

Expansion study phase: After the dose escalation stage is completed, based on the safety, PK results and preliminary efficacy data of each dose group during the escalation stage, the recommended dose will be determined for the dose expansion study. It is planned to include 3 to 6 subjects to further systematically evaluate the safety and efficacy of the universal STAR-T cell.

This study includes the screening period (from D-28 to D-6), the pre-clearance treatment and rest observation period (from D-5 to D-1), the cell infusion and main study endpoint observation period (from D0 to W12 after infusion), and the follow-up period (from W12 after infusion to W104).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Aged from 18 to 65 years (inclusive), with no gender restriction.

According to the revised 2024 McDonald diagnostic criteria, they are clinically diagnosed with progressive MS (including primary progressive PPMS or secondary progressive SPMS) or relapsing-remitting MS (RRMS), and their disability status at the time of screening meets an EDSS score of 2-7 (inclusive).

For RRMS patients, they need to meet any of the following conditions: a) They have failed treatment with ≥1 effective DMT (fenogomide, cinemodide, ozamod, and anti-CD20 monoclonal antibody therapy, etc.); b) They have had at least 2 clinical relapses in the past 2 years, or they have had 1 clinical relapse in the past 2 years and MRI shows ≥1 new Gd-enhanced lesion, or they have had ≥1 new Gd-enhanced lesion on MRI within the past 6 months; c) There are ≥2 active Gd-enhanced lesions on T1-weighted brain MRI at the time of screening.

Bone marrow function should satisfy: a. Neutrophil count ≥ 1×109/L (no colony-stimulating factor treatment within 2 weeks before the examination, and neutrophil reduction caused by the disease is excluded); b. Hemoglobin ≥ 60g/L;

Disqualifiers

1. The period of using immunosuppressants with therapeutic effects on the disease before enrollment is within five half-lives or the biological agents have been used for 4 weeks. For subjects who have received rituximab treatment, the time since the last use of rituximab is less than 3 months (except for those with B-cell reconstitution);

2. Have a severe history of drug allergy or are allergic constitution;

3. Have uncontrollable or require treatment infections such as fungi, bacteria, viruses, etc.;

4. Have active tuberculosis at the time of screening;

Trial design

Design model

Single group

Treatments tested in this trial

  • Universal STAR-T Cell Injection

    Drug

    Subjects will receive Universal STAR-T Cell Injection, and dose escalation will commence at 1.5E6 cells/kg or the starting dose may be adjusted based on accumulated data.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Universal STAR-T Cell InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity

Time frame
Within 28 days after infusion
2

The types, severity and frequency of adverse events (AE)

Time frame
Within 6 months after infusion

Secondary outcomes

1

Efficacy endpoint

Definition of treatment effectiveness: An increase in the EDSS score (an increase of 1 point for scores below 5 and 0.5 points for scores of 5 and above) is defined as deterioration. If no deterioration occurs, it is considered effective; or a reduction in the Annualized Relapse Rate (ARR).

Time frame
Within 12 weeks after infusion
2

The in vivo expansion and persistence of universal STAR-T cells.

Key PK parameters: peak amplification (Cmax), time to peak (Tmax), area under the blood concentration-time curve (AUC), as well as studies on cell subtypes and dominant clones, etc. Key PD parameters: changes in cytokines, levels and characteristics of immune cell reconstitution such as CD19-positive B cells, etc. Research on immunogenicity and other aspects: Studies on the production of anti-drug antibodies (ADA) in peripheral blood against the universal STAR-T cell injection solution and the generation of replication-type adeno-associated viruses (RCA).

Time frame
Within 12 months after infusion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daishi Tian

Lead sponsor

Tongji Hospital

Sponsor institution

China Immunotech (Beijing) Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: